Product Development and CTM Manufacturing
Frontage’s formulation development and CTM manufacturing team with extensive product development and clinical trial manufacturing experience designs formulations for targeted delivery of a therapeutic and then develops GMP manufacturing processes to ensure a high-quality product is produced for clinical trials. We develop finished products supporting IND, NDA filings, and generic ANDA filings. Our facilities have been designed for flexibility, as we offer a variety of dosage forms and the ability to handle highly-potent compounds and DEA-controlled substances. We have the equipment needed to model processes on the bench and pilot scales for technology transfer to large-scale manufacturing. We complement these capabilities with our good manufacturing practices (GMP) and manufacturing areas for preclinical, Phase I, and II clinical supplies.
Our team of expert scientists quickly identifies product complexities to develop your compounds. Our dedicated team takes you through each step of the product development process, from beginning to end.
- Raw material Selection
- Formulation Development including control substance products
- Generic product development for ANDA
- Formulation and CTM batch sizes: oral solids up to 30 Kg; Semi-solid up to 300kg; Sterile up to 20 L; high potency up to 10kg.
- CTM manufacturing (GLP batch for animals and GMP batch for human clinical trials for IND
- Aseptic processing and filling
- Single-use-systems, or product-dedicated process equipment
- Labeling and packaging
- Stability storage and testing
- Regulatory filing support
- Potent compound handling for occupational exposure levels down to 1μg/m3 (or Safebridge Category III)
- DEA licenses for analytical testing and manufacturing (Schedules I-V for analytical and manufacturing)
Choose Frontage – Choose Confidence
Documented processes and dedicated team members support all aspects of product development and clinical trial material manufacturing for all major dosage forms, including solid oral dosage forms, topical creams, gels, and ointment, oral solutions and suspensions, and sterile solutions. Frontage product development strategy incorporates QbD resulting in an optimized formulation and a robust process with an established design space.
We partner with our customers at every stage of the product development process. This approach leads to a product that has a high potential for success during scale-up and commercialization. Every client is assigned a project team that stays with their business from beginning to end, ensuring full GMP compliance. After the accomplishment of the development of an acceptable formulation and test batches of finished dosage forms produced, Frontage has the capability to develop and validate analytical methods to perform analytical testing on the finished dosage forms. Combining formulation development expertise with analytical solutions and Clinical Trial Manufacturing for your program assures a product that is compliant and developed with the proper clinical manufacturing procedures.